FDA Releases New Draft Guidance on Interchangeability 

Recently, the FDA released draft guidance on the way it evaluates interchangeable biosimilars. Interchangeability is a regulatory designation that allows pharmacists to automatically substitute a biosimilar for its reference drug, similar to generics. Currently applicants need to show that a patient could be switched from the reference product to the biosimilar and back without issue. Based on updated scientific understanding, the FDA now believes the safety and efficacy risks are insignificant and has decided to revise the interchangeability guidance such that switching studies are no longer required. In the draft guidance, the FDA proposes allowing biosimilar manufacturers to submit data that demonstrates that a biosimilar meets the switching standard without conducting a switching study. This new policy applies retroactively to pending biosimilar applications.

The FDA requested removal of the statutory distinction between the approval standard for biosimilars and interchangeable biosimilars in its budget request this year, so this revised approach was not surprising. The Cigna Group has advocated for years for a safe, effective way to speed approval and market entry of biosimilars and supports removal of the statutory distinction. We plan to comment in support of the draft guidance by the Aug. 20 deadline.